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FDA investigates Deaths linked to Baby Formula

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The U.S. Food and Drug Administration says it’s investigating nine infant deaths possibly linked to Abbott Nutrition baby formula

U.S. authorities say they’ve started to investigate the deaths of at least nine babies beginning in 2021. All the dead were allegedly fed Abbott Nutrition baby formula before becoming ill, the FDA said on June 10.

The FDA had, until recently, acknowledged just two fatal cases and two in which infants fell ill after eating formula from an Abbott Nutrition plant in Sturgis, Michigan. The watchdog said it believes the formula may have been contaminated with the cronobacter sakazakii bacterium.

FDA officials said they could not pinpoint the source of the infection that caused any of the nine infant deaths. Genomic sequencing showed infants who had succumbed to cronobacter were infected with strains different from the one discovered at the Abbott Nutrition plant during a Spring 2022 inspection. The Washington Post reported that, in some cases, there wasn’t sufficient formula left to properly test it.

The website eFoodAlert and food safety expert Phyllis Entis reported the first concerns about the formula. Ms. Entis obtained access to the complaints through a Freedom of Information Act request. Her FOIA request found 128 consumer complaints were lodged with the FDA between December 2021 and March 2022.

In addition to the nine deaths, the complaints described 25 cases where babies suffered “life-threatening illness/injury,” with an additional 80 babies sustaining “non-life-threatening illness/injury.” However, the Post reports most of the complaints weren’t corroborated by medical professionals.

With an apparent lack of hard evidence showing a link between formula produced at the Sturgis plant and illness, the FDA said that based on its “thorough review and investigation of all 128 consumer complaints reported to the agency. . . only four complaints could be included in the case series associated with the Abbott Nutrition investigation.

Abbott denies Deaths linked with its company’s products

Abbott Nutrition claimed in its own statement on June 10 that none of the reported deaths were linked with its products:

Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.

Abbott will not, however, be able to deny that FDA found problems at the Sturgis, Mich. plant.

“Egregiously Unsanitary” and “Shocking” Conditions at Sturgis Plant

During testimony before Congress in late May, FDA Commissioner Robert Califf described the conditions at Abbott’s Sturgis plant as “egregiously unsanitary” and “shocking.

After the FDA checked on improvements made at the plant, Abbott reopened it on June 11, 2022.

The Sturgis facility was shut down by the watchdog back in February 2022.

Because Abbott Nutrition’s output accounted for about 40% of all baby formula sold in the US, the closure contributed to a shortage in the market, which still obtains in the country.


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by Matthews & Associates

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